More help for your diabetic patients
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Title:
More help for your diabetic patients
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Watch-Like Diabetes Monitor OK'd
By LAURAN NEERGAARD
.c The Associated Press
WASHINGTON (AP) - Diabetics are about to get a science fiction-like way to
measure their blood sugar painlessly: The government approved a
wristwatch-looking device Thursday that uses tiny electric currents to
monitor diabetes.
The long-awaited GlucoWatch won't completely replace diabetics' dread
finger-prick blood tests because it's not perfect, the Food and Drug
Administration warned. Nor is it for children, a disappointment to parents
anxiously awaiting pain-free alternatives to sticking little fingers.
But it does promise adult diabetics important benefits: supplementing finger
testing for more frequent glucose monitoring that may keep them healthier,
and sounding an alarm if blood sugar hits dangerous levels - possibly
lifesaving if that happens during sleep.
``This particular device is going to allow patients to have an early warning
signal'' that less frequent blood tests don't allow, explained Dr. Bernard
Statland, FDA's medical device evaluation chief.
Manufacturer Cygnus Inc., which struggled three years to win FDA approval of
the prescription-only GlucoWatch, revealed Thursday that most people will
have to wait until around year's end to buy it. Cygnus hasn't scaled up
manufacturing to make enough, so immediate sales will be to about 150
patients in test marketing to ensure diabetics use it properly.
The GlucoWatch will cost $400, plus a $4 to $5 disposable sensor that the
patient must replace every 12 hours. To get a doctor's prescription for a
watch, the FDA is requiring that patients be trained to use it and pass a
quiz.
The GlucoWatch is a good first step toward diabetics' ultimate goal of
continual, painless glucose monitoring, said Dr. Christopher Saudek,
president-elect of the American Diabetes Association.
Supplementing fingerstick tests can be very helpful, and some diabetics have
longed for the watch, he said. But, Saudek cautioned, ``it still has
development to go before it becomes something that would be used for all
comers.''
Some 16 million Americans, the vast majority adults, have diabetes, meaning
their bodies cannot properly regulate blood sugar, or glucose. They check
their levels by pricking a finger and placing a drop of blood on reactive
strips.
Frequent testing, four to eight times a day, helps maintain tight control
over glucose levels and lower chances of debilitating complications such as
blindness, kidney disease and nerve damage. But the tests are painful and
inconvenient, leading many to test only twice a day. Even frequent testers
cannot know if glucose soars or drops between testing or during sleep.
To use the prescription-only GlucoWatch, patients slide a thin plastic sensor
onto the watch's back. Small electric currents extract a tiny portion of
glucose from fluid in skin cells instead of blood, measuring it every 20
minutes.
Never use insulin or make medication adjustments without first
double-checking a GlucoWatch reading with a fingerstick test, the FDA warned.
While the GlucoWatch generally is as good as blood tests, a quarter of the
time its readings can differ by about 30 percent. That's particularly a
concern in detecting hypoglycemia, blood sugar that drops below a measure of
70.
But Cygnus says patients can program the GlucoWatch to sound an alarm before
glucose plummets too low, giving time for a blood test.
Also, the watch won't measure if the patient's arm becomes too sweaty and is
less effective at detecting very low glucose than very high levels, the FDA
cautioned.
For now, only adults can use it because doctors don't know if GlucoWatch's
skin cell fluid measurements correlate to blood measurements in children as
they do in adults, cautioned FDA medical reviewer Pat Bernhardt. Cygnus is
studying the GlucoWatch with children.
On the Net: FDA: <URL Redacted>
Cygnus site: <URL Redacted>
By LAURAN NEERGAARD
.c The Associated Press
WASHINGTON (AP) - Diabetics are about to get a science fiction-like way to
measure their blood sugar painlessly: The government approved a
wristwatch-looking device Thursday that uses tiny electric currents to
monitor diabetes.
The long-awaited GlucoWatch won't completely replace diabetics' dread
finger-prick blood tests because it's not perfect, the Food and Drug
Administration warned. Nor is it for children, a disappointment to parents
anxiously awaiting pain-free alternatives to sticking little fingers.
But it does promise adult diabetics important benefits: supplementing finger
testing for more frequent glucose monitoring that may keep them healthier,
and sounding an alarm if blood sugar hits dangerous levels - possibly
lifesaving if that happens during sleep.
``This particular device is going to allow patients to have an early warning
signal'' that less frequent blood tests don't allow, explained Dr. Bernard
Statland, FDA's medical device evaluation chief.
Manufacturer Cygnus Inc., which struggled three years to win FDA approval of
the prescription-only GlucoWatch, revealed Thursday that most people will
have to wait until around year's end to buy it. Cygnus hasn't scaled up
manufacturing to make enough, so immediate sales will be to about 150
patients in test marketing to ensure diabetics use it properly.
The GlucoWatch will cost $400, plus a $4 to $5 disposable sensor that the
patient must replace every 12 hours. To get a doctor's prescription for a
watch, the FDA is requiring that patients be trained to use it and pass a
quiz.
The GlucoWatch is a good first step toward diabetics' ultimate goal of
continual, painless glucose monitoring, said Dr. Christopher Saudek,
president-elect of the American Diabetes Association.
Supplementing fingerstick tests can be very helpful, and some diabetics have
longed for the watch, he said. But, Saudek cautioned, ``it still has
development to go before it becomes something that would be used for all
comers.''
Some 16 million Americans, the vast majority adults, have diabetes, meaning
their bodies cannot properly regulate blood sugar, or glucose. They check
their levels by pricking a finger and placing a drop of blood on reactive
strips.
Frequent testing, four to eight times a day, helps maintain tight control
over glucose levels and lower chances of debilitating complications such as
blindness, kidney disease and nerve damage. But the tests are painful and
inconvenient, leading many to test only twice a day. Even frequent testers
cannot know if glucose soars or drops between testing or during sleep.
To use the prescription-only GlucoWatch, patients slide a thin plastic sensor
onto the watch's back. Small electric currents extract a tiny portion of
glucose from fluid in skin cells instead of blood, measuring it every 20
minutes.
Never use insulin or make medication adjustments without first
double-checking a GlucoWatch reading with a fingerstick test, the FDA warned.
While the GlucoWatch generally is as good as blood tests, a quarter of the
time its readings can differ by about 30 percent. That's particularly a
concern in detecting hypoglycemia, blood sugar that drops below a measure of
70.
But Cygnus says patients can program the GlucoWatch to sound an alarm before
glucose plummets too low, giving time for a blood test.
Also, the watch won't measure if the patient's arm becomes too sweaty and is
less effective at detecting very low glucose than very high levels, the FDA
cautioned.
For now, only adults can use it because doctors don't know if GlucoWatch's
skin cell fluid measurements correlate to blood measurements in children as
they do in adults, cautioned FDA medical reviewer Pat Bernhardt. Cygnus is
studying the GlucoWatch with children.
On the Net: FDA: <URL Redacted>
Cygnus site: <URL Redacted>
Citation
“More help for your diabetic patients,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 1, 2024, https://library.drfop.org/items/show/216127.
